中欧医疗器械市场监督管理的比较及启示

文章通过对欧洲医疗器械市场监督管理工作的介绍、分析,以及与我国相关工作的对比,指出我国需要在学习国外先进经验的基础上建立系统的医疗器械市场监督(MS)法规体系和监管网络。     

中欧医疗器械市场监督管理的比较及启示

文章通过对欧洲医疗器械市场监督管理工作的介绍、分析,以及与我国相关工作的对比,指出我国需要在学习国外先进经验的基础上,建立系统的医疗器械市场监督(MS)法规体系和监管网络.     

依照法规监督管理医疗器械

医疗器械监督管理条例是我国首都医疗器械监督管理的法规。依照法规监督管理医器械,使之进入法制化管理轨道。     

医疗器械监督管理条例

国务院第24次常务会议审议通过的《医疗器械监督管理条例》已于2000年1月4日朱镕基总理签发276号国务院令正式颁布(以下简称276号令),并将于2000年4月1日正式施行。 医疗器械作为医疗服务中诊断和治疗的工具,其安全性和有效性直接关系医疗效果和病人的生命安全,但长期以来由于缺乏相关的法规,致使有关部门和使用单位难以对医疗器械实施严格的管理和监督,医疗器械研究、生产、流通、使用诸环节存在不少问题,甚至目前问题相当严重。据了解,我国现有医疗器械生产企业近5000家,并以年均18％左右的增长速度发展,年产值约300亿元,另有近千家国外公司向我国出口近百种(类)医疗器械,年销售额10多亿美元,其中一些质量低劣的医疗器械流入市场和医疗机构,甚至还有二手设备和报废设备,如象二手CT,竟达到现有CT的一半,令人震惊的是二手机中劣质CT机竟占1/2以上,甚至不能成像、开机。国内医疗器械合格率长期在70％左右俳徊,这些不仅严重扰乱了我国医疗器械市场的正常秩序,而且给使用的医疗卫生单位和患者造成无法估量的损失。这不仅严重威胁广大病人的生命与健康,而且也影响着我国医疗器械产业的健康安全。 276号令的颁布,使我国医疗器械的监督与管理结束无法可依的历史,标志着我国医疗器械监督管理将走上法制化轨道。     

关于医疗器械软件上市后监管机制探讨

随着信息技术与医疗技术高速发展和融合,软件在医疗机构疾病诊断与治疗中起到愈来愈重要的作用。同时由于软件缺陷带来医疗事故也日渐增多,加强对医疗器械软件产品上市后监管非常必要且紧迫。     

医疗器械上市后的监督管理如何面对入市后的挑战

随着《医疗器械监督管理条例》的颁布实施以及相关配套规章的陆续出台,标志着我国医疗器械的管理进入了法制化、规范化和依法监督的新时期。我国加人WTO后,政府管理部门面临着在建设有中国特色的监督管理机制的同时,还要逐步与国际通行的管理机制接轨。因此,如何面对入市后的新形势,改变以往较注重行政审批的旧观念,把监督管理的重心移到上市后的监督上来,建立起有效的监督体制,保证人民群众安全、有效的使用医疗器械,是政府管理部门急需研究解决的一道课题。 从目前情况上看,通过医疗器械上市前进行注册审批,基本建立了医疗器械的准入制度。但是,医疗器械上市后的监督工作方面相对却比较薄弱,急需建立完善的监督体系进行监管,以保证前期的准入工作得到落实,保证后期医疗器械     

中美医疗器械生产企业监督管理之比较与借鉴

比较中美两国对医疗器械生产企业监督管理的一般规定、生产的质量体系检查、生产企业的市场准入要求和上市后的监测等方面的差异。     

医疗器械监督管理现状的分析

目的:论述了如何保障医疗器械生产加工、批发零售、交易等环节的监管质量应从源头治理。方法:根据我国现有医疗资源和医学工程技术管理人员资源,进一步强化医疗器械监管力度。结果:严把医疗器械市场准入关,对采购、验收、使用要监管。结论:确保上市医疗器械质量安全有效,让患者放心。     

中欧医疗器械不良事件报告系统的比较及对我国的启示

我国医疗器械不良事件报告系统的建设尚在起步阶段,而欧盟已经建立了相对完善的医疗器械不良事件报告体系。通过介绍,分析并比较中欧医疗器械不良事件报告系统,旨在为我国医疗器械不良事件报告管理工作提供借鉴。     

医疗器械上市后安全性监测框架模式的构建实例研究

针对心脏瓣膜典型案例,围绕信息收集、分析评价及控制环节存在的问题及可借鉴的经验进行访谈,剖析医疗器械上市后安全性监测过程中可能存在的问题,并提出改进建议。     

医疗器械的售后监督

根据国际标准ISO14971及欧盟医疗器械法令93/42/EEC的有关要求,着重介绍了售后监督活动在医疗器械产品中的应用现状、实施重点和发展趋势,结合医疗器械生产企业对售后监督的实践经验,为医疗器械生产企业如何理解、实施售后监督提出了方法和建议。     

Considerations on occupational medical surveillance in employees handling nanoparticles

Objectives The use of engineered nanoparticles not only offers new technical perspectives but also raises questions regarding possible health aspects for producers and users. Nanoparticles may, just by virtue of their size, exert biological effects unrelated to the chemicals they are composed of. These considerations, and results from experimental animal studies suggesting that engineered nanomaterials may pose a health hazard to employees, all underscore the need for preventive measures. In this context, the need for, the feasibility, and the appropriateness of targeted occupational medical surveillance are currently subject to debate. Methods We compared established concepts for the development of occupational medical surveillance programs to existing knowledge on exposures in workplaces and on health effects of nanomaterials. Results A variety of potential effect parameters have been proposed for medical surveillance of exposed personnel, such as heart rate variability, blood-clotting parameters, pro-inflammatory cytokines, etc. None of these parameters are specific, most are not validated as individual health risk indicators, and some require sophisticated equipment not routinely available. Against this background, BASF currently puts specific weight on risk assessment and exposure control in workplaces. Particle emissions are primarily avoided by manufacturing in closed systems or using effective extraction systems. Appropriate personal protective equipment has been defined for such operations where an exposure potential cannot be excluded. Conclusions While there is presently no evidence-based foundation for “nano-specific” occupational medical screening, one can perform general medical screening with methods targeted at some of the health outcomes under discussion. The results of such examinations can provide a basis for future epidemiologic studies. Therefore, the establishment of exposure registries to enable the conduct of large-scale multi-centric prospective epidemiologic studies is recommended.     

Exposure limits and medical surveillance in occupational health

The standards for pollutants in workplace air constitute a social consensus or agreement about acceptable levels of occupational hygiene. This agreement to exposures up to these limits inevitably includes a finite risk to the health of the workers. The numeric values of standards are needed to assess the requirements for ventilation and other occupational hygiene conditions. Planning and everyday practice in industry also need hygienic stan- dards so that practical hygienic and safety measures can be maintained. These standards are not, however, levels below which there is no risk to health. While the hygienic stan- dard itself carries acceptance of a certain risk, doctors cannot ethically accept any health risk to workers whatever the source of exposure. Thus personnel working in occupa- tional health have to think about the risks of ill health even when the hygienic standards are met. The physician in occupational health has to be especially concerned to discover and estimate the risks to anyone particularly susceptible to exposures within the hygien- ically acceptable conditions. To do this, the occupational health physician uses medical examinations and specific investigations. In the follow-up of workers, health occupa- tional health personnel use medical examinations in order to detect possible risks or to assess the general health status of individual workers. Health examinations are also used to detect specific injuries caused by the agents to which workers are known to be exposed in their work.     

影响病区空气监测结果的相关因素研究

目的　做好病区空气中微生物的监测工作,防范医院感染。方法　模拟一种日常工作中的监测环境,分别在同一时间以不同位置、不同温度培养基和不同培养皿盖口放置方向进行空气微生物采样,采样后将培养皿经37℃培养2 4h ,根据各菌落数的生长情况进行原因分析。结果　同一房间不同位置菌落数( x±s) ,窗口边<房中央<墙角边;直接取自冰箱的培养皿培养菌落数少于预温后的培养皿菌落数;培养皿盖口向上时,采样培养的菌落数大于盖口向下时。结论　病区临床科室在做空气微生物监测时,应保持消毒前后条件一致,采样前培养基的温度、采样时平皿放置方式对监测结果影响大。     

Analysis of medical screening and surveillance in 21 occupational safety and health administration standards: Support for a generic medical surveillance standard

Twenty-one Occupational Safety and Health Act (OSHA) standards were identified which contain medical service provisions intended to help in the identification and control of harmful health effects of workplace exposures. The utility and effectiveness of these provisions have not previously been evaluated. All 21 standards were reviewed and assigned numerical scores for each of 24 potential medical program elements. Several of these elements were combined to calculate Quality Control, Screening Utility, and Surveillance Utility scores for each standard. Total scores varied greatly, suggesting a lack of consistency and uniformity which was even more obvious when the actual regulatory language was examined. The mean Quality score was only 26% of potential points. Seventeen of 21 standards received less than half the total possible Quality score. When arrayed on a two by two matrix only two standards scored above 50% for both Screening and Surveillance Utility. It was concluded that the medical service provisions in OSHA standards are lacking in consistency and coherence. Two major shortcomings are the lack of quality control elements and the absence of surveillance features which would permit medical program results to be utilized for prevention activities including the identification and control of workplace hazards. A generic occupational medical surveillance standard could address these current weaknesses. Elements of such a generic standard are proposed.     

Prevention of occupational asthma including medical surveillance

The high figures of occupational asthma worldwide necessitate the intensification of appropriate primary, secondary, and tertiary preventive measures. Based on new scientific data on dose-response relationships as well as our own experience and ethical aspects, we focus on medical surveillance within the framework of secondary prevention. We propose that medical surveillance programs be mandatory for workplaces/occupations with an asthma incidence of ≥200% than that of the general population. Medical surveillance programs are recommended if asthma frequency is elevated but below 200%. A stepwise approach of monitoring workers at risk for developing occupational asthma including a screening by questionnaire and a personal interview and diagnosis confirmation is presented. In addition, we briefly comment on the management of affected subjects. Am. J. Ind. Med. 34:632–639, 1998. © 1998 Wiley-Liss, Inc.     

Fatal infectious disease surveillance in a medical examiner database

Increasing infectious disease deaths, the emergence of new infections, and bioterrorism have made surveillance for infectious diseases a public health concern. Medical examiners and coroners certify approximately 20% of all deaths that occur within the United States and can be a key source of information regarding infectious disease deaths. We hypothesized that a computer-assisted search tool (algorithm) could detect infectious disease deaths from a medical examiner database, thereby reducing the time and resources required to perform such surveillance manually. We developed two algorithms, applied them to a medical examiner database, and verified the cases identified against the opinion of a panel of experts. The algorithms detected deaths with infectious components with sensitivities from 67% to 94%, and predictive value positives ranging from 8% to 49%. Algorithms can be useful for surveillance in medical examiner offices that have limited resources or for conducting surveillance across medical examiner jurisdictions.